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The instruction for medical use of VIV Famtsiklovir medicine the PHARMACEUTICAL Trade name Famtsiklovir of VIV the PHARMACEUTICAL International unlicensed name Famtsiklovir Lekarstvennaya the Tablet form, film coated 125 mg and 250 mg Structure One tablet contains active agent – famtsiklovir 125 mg or 250 mg, excipients: lactoses monohydrate, sodium glikolit starch, hydroxypropyl cellulose, magnesium stearate, structure of a cover: (Opadry OY-S-28924): gipromelloza, titan dioxide (E171), polyethyleneglycol. Description Round biconvex tablets, film coated white color. Pharmacotherapeutic group Antiviral drugs of direct action. Nucleosides and nucleotides. Famtsiklovir. ATH J05AB09 code the Pharmacological Pharmacokinetics At properties oral administration famtsiklovir quickly and effectively is absorbed and turns into active anti-virus connection – pentsiklovir. The bioavailability of a pentsiklovir after oral administration of a famtsiklovir is 77%. Average sizes of plasma concentration of a pentsiklovir after oral administration of a famtsiklovir in doses of 125 mg and 250 mg are, respectively, 0.8 mkg/ml and 1.6 mkg/ml and are noted on average in 45 minutes after reception of a dose. Curves plasma concentration / time for a pentsiklovir are identical at single and repeated (3 times a day and 2 times a day) to a dosage that demonstrates lack of cumulation of a pentsiklovir at repeated dosing of a famtsiklovir. Food does not influence degree of system availability (AUC) of a pentsiklovir. Pentsiklovir and his 6-deoksi-predecessor poorly (& lt, 20%) contact proteins of blood plasma. Famtsiklovir is allocated, mainly, in the form of a pentsiklovir and his 6-deoksi-predecessor which are excreted with urine, at the same time not changed famtsiklovir in urine it is not found. Canalicular secretion promotes renal elimination of connection. The final half-life period of a pentsiklovir after reception both single, and repeated doses of a famtsiklovir is about 2 hours. Data of preclinical trials podemonstrirovat lack of induction tsitokhromv P450 and inhibition of CYP3A4. The pharmacokinetics in special cases Patients with the infection caused by the Varicella zoster virus In patients with the uncomplicated infection caused by the Varicella zoster virus does not come to light significant changes of pharmacokinetic parameters of a pentsiklovir (elimination half-life of drug in a final phase after reception single and repeated doses of a famtsiklovir makes 2.8 and 2.7 hours of blood plasma, respectively) Patients with renal failures After reception single and repeated doses of a famtsiklovir the linear dependence between decrease in plasma clearance, renal clearance, clearance rate of a pentsiklovir from blood plasma and degree of a renal failure is noted. Pharmacokinetic features of use of drug for patients with heavy (dekompensirovanny) renal failures were not studied. Patients with abnormal liver functions At patients with abnormal liver functions of light and average severity the increase in AUC value of a pentsiklovir is not observed. The pharmacokinetics of a pentsiklovir at patients with heavy abnormal liver functions was not studied. Transformation of a famtsiklovir into an active metabolite pentsiklovir at this group of patients can be broken that leads to lowering of concentration of a pentsiklovir in plasma and, as a result, to decrease in efficiency of a famtsiklovir. Patients are aged more senior than 65 years At patients aged from 65 up to 70 years the increase in average AUC value of a pentsiklovir approximately for 40% and decrease in its renal clearance approximately by 20% in comparison with persons is noted 65 years are younger. These pharmacokinetic features of a pentsiklovir can be partially caused by age changes of renal function at patients 65 years are more senior. Paul Paul of the patient has no significant impact on pharmacokinetic parameters of drug (insignificant differences in clearance of a petsiklovir at men and women). Race At use of a famtsiklovir (single or multiple dose in a dose 500 mg, 1, 2 or 3 times a day) pharmacokinetic parameters of drug at healthy volunteers of negroid race and at patients of negroid race with renal failures or a liver did not differ from those at persons of Caucasian race. The pharmacodynamics At intake Famtsiklovir quickly turns in pentsiklovir which is active concerning the Varicella zoster and Herpes simplex viruses (type 1 and 2), a virus of chicken pox, Epstein-Burra’s virus and a cytomegalovirus. In the cells infected with a virus under the influence of a virus thymidinekinase pentsiklovir quickly and effectively turns into monophosphate which in turn passes into triphosphate. The period of intracellular semi-removal of a pentsiklovir of triphosphate for the culture of the cells infected with Herpes Simplex 1 is 10 hours, Herpes Simplex of 2 – 20 hours, Varicella zoster – 7 hours. Concentration of a pentsiklovir of triphosphate in not infected cells does not exceed minimum defined therefore in therapeutic concentration pentsiklovir does not influence not infected cells. Pentsiklovira triphosphate is in the infected cells over 12 hours and oppresses replication of virus DNA (deoxyribonucleic acid). In not infected cells under the influence of a pentsiklovir the concentration of pentsiklovir-triphosphate is hardly defined. Therefore, the probability of its toxic action on own cells of an organism very low and for not infected cells the damage by therapeutic concentration of a pentsiklovir is improbable. The most often found resistance form to a pentsiklovir, as well as to acyclovir, among herpes simplex virus strains, are the mutations in a gene of a virus thymidinekinase resulting in deficit or disturbance of a substratspetsifichnost of enzyme. Significantly less often changes in DNK-polimeraznom a gene meet. However the activity of a pentsiklovir concerning recently allocated atsiklovirastvorezistentny virus strains of a herpes simplex with the damaged DNA polymerase was shown. There are no data confirming resistance of virus strains of a herpes simplex to a pentsiklovir. The indications of the Infection caused by the Varicella zoster virus – treatment of shingles, including oftalmogerpes at immunocompetent adult patients – treatment of shingles at adult patients with the weakened immunity of the Infection, caused by the Herpes simplex viruses – treatment of the first manifestations and a recurrence of genital herpes at immunocompetent adult patients – treatment of a recurrence of genital herpes at adult patients with the weakened immunity – suppression of recurrent genital herpes at immunocompetent adult patients and at adult patients with the weakened immunity are the Route of administration and doses Shingles and oftalmogerpes, caused by the Varicella zoster virus in immunocompetent adult patients On 500 mg 3 times a day within 7 days. Treatment should be begun as soon as possible after establishment of the diagnosis. Shingles at adult patients with the weakened immunity On 500 mg 3 times a day within 10 days. Treatment should be begun as soon as possible after establishment of the diagnosis. Genitaltny herpes at immunocompetent adult patients In primary genital herpes the recommended dose of drug makes 250 mg 3 times a day within 5 days. In recurrent genital herpes drug is appointed 125 mg by 2 times a day within 5 days. It is recommended to begin treatment at the first symptoms of a recurrence (pricking, an itching, burning, pain or rashes). At suppressive therapy of recurrent genital herpes appoint 250 mg of drug 2 times a day. It is recommended to carry out the assessment of suppressive therapy at most in 12 months of continuous therapy for determination of frequency and weight of a recurrence. The minimum term of evaluating has to include two recurrence. Genitaltny herpes at adult patients with reduced immunity In recurrent genital herpes the recommended drug dose – 500 mg 2 times a day within 7 days. It is recommended to begin treatment at the first symptoms of a recurrence (pricking, an itching, burning, pain or rashes). At suppressive therapy of recurrent genital herpes appoint 500 mg of drug 2 times a day. Patients with renal failures. At patients with renal failures the reduction of clearance of a pentsiklovir, active metabolite of a famtsiklovir is noted. Correction of the mode of dosing depending on clearance (Cl) of creatinine is provided in the table. The table 1 Dosing Mode for adult patients with a renal failure of the Indication and the mode of dosing Cl of creatinine, ml/min. the Corrected dosing mode Shingles at immunocompetent adult patients of 500 mg 3 times a day within 7 days ≥ 60,500 mg 3 times a day within 7 days of 40-59,500 mg 2 times a day within 7 days of 20-39,500 mg of 1 times a day within 7 days & lt, 20,250 mg of 1 times a day within 7 days the Patients who are on a hemodialysis of 250 mg after each session of dialysis Shingles at adult patients with the weakened immunity of 500 mg 3 times a day within 10 days ≥ 60,500 mg 3 times a day within 10 days of 40-59,500 mg 2 times a day within 10 days of 20-39,500 mg of 1 times a day within 10 days & lt, 20,250 mg of 1 times a day within 10 days the Patients who are on a hemodialysis of 250 mg after each session of dialysis Genital herpes at immunocompetent adult patients Primary genital herpes of 250 mg 3 times a day within 5 days ≥ 40,250 mg 3 times a day within 5 days of 20-39,250 mg 2 times a day within 5 days & lt, 20,250 mg of 1 times a day within 5 days Patients, being on a hemodialysis of 250 mg after each session of dialysis within 5 days Recurrent genital herpes of 125 mg 2 times a day within 5 days ≥ 20,125 mg 2 times a day within 5 days & lt, 20,125 mg of 1 times a day within 5 days Patients, being on a hemodialysis of 125 mg after each session of dialysis within 5 days Suppression of recurrent genital herpes of 250 mg 2 times a day ≥ 40,250 mg 2 times in day of 20-39,125 mg 2 times a day & lt, 20,125 mg of 1 times a day the Patients who are on a hemodialysis of 125 mg after each session of dialysis Genital herpes at patients with the weakened immunity Recurrent genital herpes of 500 mg 2 times a day within 7 days ≥ 40,500 mg 2 times a day within 7 days of 20-39,500 mg of 1 times a day within 7 days & lt, 20,250 mg of 1 times a day within 7 days the Patients who are on a hemodialysis of 250 mg after each session of dialysis Suppression of recurrent genital herpes of 500 mg 2 times a day ≥ 40,500 mg 2 times in day of 20-39,500 mg of 1 times a day & lt, 20,250 mg of 1 times a day Patients, being on a hemodialysis of 250 mg after each session of dialysis the Patients with a renal failure who are on a hemodialysis. As after carrying out a 4-hour hemodialysis the concentration of a pentsiklovir in plasma decreases by 75%, Famtsiklovir VIV PHARMACEUTICAL should be accepted right after the procedure of a hemodialysis. Patients with abnormal liver functions. For patients with abnormal liver functions of light and average severity the dose adjustment of drug is not required. Use for children the Efficiency and safety of use of the drug Famtsiklovir of VIV PHARMACEUTICAL at children is not established. Patients of advanced age Modification of a dosage is not required if there are no renal failures. Side effects Very often (& gt, 1/10) a headache Often (& gt, 1/100, & lt, 1/10) dizziness nausea, vomiting, abdominal pain, diarrhea abnormal indicators of function of a liver skin rashes, an itching Infrequently (& gt, 1/1000, & lt, 1/100) confusion of consciousness (mainly at elderly) drowsiness (mainly at elderly) a Quincke’s disease (a face edema, the century, periorbital hypostasis, a laryngeal edema), a small tortoiseshell Seldom (& gt, 1/10000, & lt, 1/1000 swelled) hallucination thrombocytopenia a cardiopalmus cholestatic jaundice Frequency is unknown serious skin reactions (multiformny erythema, Stephens-Johnson’s syndrome, a toxic epidermal necrolysis), a leykotsitoklastichesky vasculitis. Undesirable reactions about which it was reported during conduct of clinical trials at patients with the weakened immunity were similar to about what about which it was reported at immunocompetent patients. It was more often reported about such phenomena as nausea, vomiting and change of indicators of a functional condition of a liver, especially at reception of higher doses. Contraindications hypersensitivity to a famtsiklovir or other components of drug, and also hypersensitivity to a pentsiklovir. children’s and teenage age up to 18 years pregnancy and the period of a lactation Medicinal interactions any clinically significant forms of interaction are noted. At simultaneous use probenetsid can increase concentration of a pentsiklovir (active metabolite of a famtsiklovir) in blood plasma due to the competition at elimination. Therefore a fortune of the patients who are coming into famtsiklovir in a dose of 500 mg 3 times a day along with probenitsidy it has to be controlled on toxicity. If patients test heavy dizziness, drowsiness, confusion of consciousness or other disturbances from the central nervous system it is necessary to consider the possibility of a dose decline of Famtsiklovir VIV 3 times, PHARMACEUTICAL up to 250 mg, a day. Transformation of an inactive metabolite of a 6-deoksipentsiklovir in pentsiklovir is catalyzed by enzyme aldehyde oxidase. Interaction with other drugs which are metabolized under the influence of this enzyme is possible and/or are inhibited by this enzyme. Clinical trials of interaction of a famtsiklovir with aldehyde oxidase inhibitors – Cimetidinum and promethazine – did not show influence on formation of a pentsiklovir. However, raloksifen, the most powerful inhibitor of aldehyde oxidase, influenced formation of a pentsiklovir and efficiency of a famtsiklovir. At simultaneous use of a famtsiklovir and raloksifen the control of clinical performance of anti-virus therapy is necessary. Clinically significant deviations in pharmacokinetics of a pentsiklovir at single use of a famtsiklovir in a dose of 500 mg after use of repeated doses of Allopyrinolum, Cimetidinum, theophylline, a zidovudine, promethazine, antacids were not observed (magnesium or aluminum hydroxide), an emtritsitabina. Clinically significant change of pharmacokinetics of a pentsiklovir at use of a famtsiklovir in a dose of 500 mg 3 times a day and repeated doses of digoxin was not observed. Medicinal interaction at combined use of a zidovudine and famtsiklovir is noted. Special instructions special attention needs to be paid on patients with impaired renal function at whom regulation of a dosage is necessary. Use by patients with a liver failure At patients with a heavy liver failure action of a famtsiklovir is not studied. Transformation of a famtsiklovir to an active metabolite pentsiklovir at such patients can be broken that can lead to decrease in concentration of a pentsiklovir in blood plasma and as a result, decrease in efficiency of action of a famtsiklovir can be observed. Use at treatment of shingles It is necessary to monitor carefully the clinical answer, especially to patients with the weakened immunity. It is necessary to consider the possibility of use of intravenous antiviral therapy if the response to oral therapy is considered insufficient. Patients with the complicated shingles, for example with the damage of internals disseminated by shingles, motor neuropathy, encephalitis and cerebrovascular complications have to perform intravenous antiviral therapy. Patients with the weakened immunity and an ophthalmologic form of shingles or to patients with high risk of spread of a disease and damage of internals need to perform intravenous antiviral therapy. Transfer of genital herpes to Patients it is necessary to recommend to avoid sexual intercourses in the presence of symptoms even if anti-virus therapy is already begun. In the course of suppressive therapy by anti-virus means virus discharge frequency significantly decreases. However the risk of transfer remains theoretically possible therefore patients have to apply appropriate means of contraception.
Whether pregnancy and the period of a lactation of the Research on animals display any embriotoksichny or teratogenic effects with famtsikloviry or pentsikloviry (an active metabolite of a famtsiklovir), however there are no sufficient data on use of a famtsiklovir for pregnant women. Therefore drug is contraindicated during pregnancy. After oral introduction of a famtsiklovir to rats in the period of a lactation, pentsiklovir it was excreted in breast milk. There is no information on excretion of a famtsiklovir in maternal milk. If the condition of the woman demands purpose of a famtsiklovir, it is necessary to stop feeding by a breast. Famtsiklovir has no significant effect on quantity of spermatozoa, morphology or their mobility. Famtsiklovir does not affect male fertility after long-term treatment at intake in a dose of 250 mg twice a day. Drug contains lactose. To patients with rare hereditary intolerance of a galactose, with deficiency of Lappa lactase or malabsorption of glucose galactose it is not necessary to apply Famtsiklovir VIV PHARMACEUTICAL. Clinical trials with participation of the patients infected with Herpes simplex in which immunosuppression is caused by the infections other than HIV were not conducted. The feature of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms is not recommended to drive the car or other potentially dangerous mechanisms when developing a headache, dizziness, confusion of consciousness or hallucinations. Overdose Symptoms: drug is well transferred. At patients with diseases of kidneys cases of an acute renal failure are noted. Treatment: in case of overdose it is necessary to carry out the supporting and symptomatic therapy. In case of an acute renal failure at patients with the previous diseases of kidneys which have a dose of the drug Famtsiklovir of VIV PHARMACEUTICAL it was not reduced according to the level of function of kidneys, it is recommended to apply a hemodialysis. A form of release and packing On 10 tablets (for a dosage of 125 mg) or 7 tablets (for a dosage of 250 mg) in blister strip packaging from a film of polyvinylchloride and aluminum foil. On 1 (for a dosage of 125 mg) or on 3 (for a dosage of 250 mg) planimetric packing together with the instruction for medical use in the state and Russian languages place in a pack from cardboard. To Store storage conditions at a temperature not above 25 °C. To store out of children’s reach! 2 years not to apply a period of storage after the expiry date specified on packing. Prescription status According to the prescription VIVA FARM LLP Producer, 2nd Ostroumova St., 33, Almaty, Republic of Kazakhstan the Owner of the registration certificate of VIVA FARM LLP, 2nd Ostroumova St., 33, Almaty, Republic of Kazakhstan the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products (goods) TOO « VIVA PHARM” 2nd Ostroumova St., 33, Almaty, RK the Address of the organization in the territory of the Republic of Kazakhstan responsible for post-registration observation of safety of medicine: VIVA FARM LLP, Republic of Kazakhstan, 2nd Ostroumova St., 33. Almaty, 050030